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REVIEWING FDA’S IMPLEMENTATION OF FDASIA 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

NOVEMBER 15, 2013 

Serial No. 113–98 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 2 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 2 

Hon. Leonard Lance, a Representative in Congress from the State of New 

Jersey, opening statement ................................................................................... 3 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 4 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 5 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 6 

WITNESSES

Janet Woodcock, Director, Center for Drug Evaluation and Research, Food 

and Drug Administration .................................................................................... 7 

Prepared statement 1 ........................................................................................ 11 

Answers to submitted questions 2 ................................................................... 61 

Jeffrey E. Shuren, Director, Center for Devices and Radiological Health, 

Food and Drug Administration ........................................................................... 8 

Prepared statement 1 ........................................................................................ 11 

Answers to submitted questions ...................................................................... 139 

1Ms. Woodcock and Mr. Shuren submitted a joint statement for the record. 

2Ms. Woodcock submitted a partial response to questions for the record. 

(1) 

REVIEWING FDA’S IMPLEMENTATION OF 

FDASIA 

FRIDAY, NOVEMBER 15, 2013 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:02 a.m., in room 

2322, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Burgess, Whitfield, 

Shimkus, Rogers, Murphy, Blackburn, Gingrey, Lance, Guthrie, 

Griffith, Bilirakis, Upton (ex officio), Pallone, Dingell, Engel, 

Capps, Green, Butterfield, Barrow, Castor, Sarbanes, and Waxman 

(ex officio). 

Staff present: Clay Alspach, Chief Counsel, Health; Sean 

Bonyun, Communications Director; Noelle Clemente, Press Secretary; Brad Grantz, Policy Director, Oversight and Investigations; 

Sydne Harwick, Legislative Clerk; Robert Horne, Professional Staff 

Member, Health; Carly McWilliams, Professional Staff Member, 

Health; Andrew Powaleny, Deputy Press Secretary; Chris Sarley, 

Policy Coordinator, Environment and the Economy; John Stone, 

Counsel, Oversight; Ziky Ababiya, Democratic Staff Assistant; Eric 

Flamm, Democratic FDA Detailee; Karen Nelson, Democratic Deputy Committee Staff Director for Health; Rachel Sher, Democratic 

Senior Counsel; and Ryan Skukowski, Democratic Staff Assistant. 

Mr. PITTS. The subcommittee will come to order. The Chair will 

recognize himself for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

The Food and Drug Administration Safety and Innovation Act, 

FDASIA, was signed into law on July 9th, 2012. The purpose of the 

bill was to bring predictability, consistency, and transparency to 

FDA’s regulation of drugs and devices. To that end, FDASIA reauthorized two successful user fee programs, the Prescription Drug 

User Fee Act, PDUFA, and the Medical Device User Fee Act, 

MDUFA, scheduled to expire at the end of fiscal year 2013. It also 

authorized two new user fee programs, for generic drugs, GDUFA, 

and biosimilars, BSUFA. In each case the industry negotiated a 

level of user fees to be paid to FDA in return for the agency meeting agreed-upon performance and accountability metrics. 

2 

Additionally, FDASIA permanently reauthorized the Best Pharmaceuticals for Children Act and the Pediatric Research Equity 

Act; reformed both the drug and medical device regulatory processes; addressed drug supply chain and drug shortage issues; and 

incentivized the development of new antibiotic drugs, among other 

provisions. The bill represents a bipartisan success not only for our 

committee, but for Congress as a whole. It passed the House by a 

voice vote and passed the Senate by a vote of 92–4. 

Now, over a year later, we are here to examine whether the law 

has been a success for the American people, resulting in safer 

drugs and devices, faster approval times, and more consistency and 

predictability in the process. There is great congressional interest, 

not only in the overall implementation of FDASIA, but also in the 

day-to-day operational challenges and successes. And I would like 

to congratulate Dr. Woodcock for what I understand is significant 

progress in the Center for Drug Evaluation and Research. 

I would like to welcome both Dr. Janet Woodcock and Dr. Jeffrey 

Shuren to the subcommittee. I look forward to hearing their testimony. And I yield 1 minute to Dr. Gingrey. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

The Food and Drug Administration Safety and Innovation Act (FDASIA) was 

signed into law on July 9, 2012. 

The purpose of the bill was to bring predictability, consistency, and transparency 

to FDA’s regulation of drugs and devices. 

To that end, FDASIA reauthorized two successful user fee programs, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), 

scheduled to expire at the end of fiscal year 2013. 

It also authorized two new user fee programs for generic drugs (GDUFA) and 

biosimilars (BSUFA). 

In each case, industry negotiated a level of user fees to be paid to FDA in return 

for the Agency meeting agreed upon performance and accountability metrics. 

Additionally, FDASIA permanently reauthorized the Best Pharmaceuticals for 

Children Act and the Pediatric Research Equity Act, reformed both the drug and 

medical device regulatory processes, addressed drug supply chain and drug shortage 

issues, and incentivized the development of new antibiotic drugs, among other provisions. 

The bill represents a bipartisan success, not only for our committee, but for Congress as a whole. It passed the House by voice vote and passed the Senate by a vote 

92 to 4. 

Now, over a year later, we are here to examine whether the law has been a success for the American people, resulting in safer drugs and devices, faster approval 

times, and more consistency and predictability in the process. 

There is great Congressional interest not only in the overall implementation of 

FDASIA, but also in the day-to-day operational challenges and successes. And, I 

would like to congratulate Dr. Woodcock for what I understand is significant 

progress in the Center for Drug Evaluation and Research. 

I would like to welcome both Dr. Janet Woodcock and Dr. Jeffrey Shuren to the 

subcommittee. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you very much for yielding. 

I, too, am pleased to see Dr. Woodcock and Dr. Shuren again today. 

FDASIA looked to address the crisis of antibiotic resistance with 

3 

Title VIII, the GAIN Act, which I wrote with my colleagues Mr. 

Green, Mr. Shimkus, Ms. DeGette, Mr. Whitfield, and Ms. Eshoo. 

By focusing on incentives to bring new drugs to market we have 

seen renewed focus on the development of cutting-edge drugs, antibiotic. However, even with the early success of this program, I do 

believe that we do need to do more. 

And so, Mr. Chairman, CDC had a September report, CDC in my 

great capital center of Atlanta, Georgia, on antimicrobial resistance, highlights 18 known resistance threats. It is estimated that 

across the country more than 2 million people are sickened every 

year with antibiotic-resistance infections resulting in at least 

23,000 deaths—23,000 deaths. 

I look forward to continuing to work with the FDA to create innovative pathways and processes. We must make sure that the agency and drug developers have as many tools as possible to navigate 

this emerging public health problem. 

And I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

And now yields the balance of time to Mr. Lance. 

OPENING STATEMENT OF HON. LEONARD LANCE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. LANCE. Thank you, Mr. Chairman. 

Today’s hearing serves as a helpful pulse check of the FDA’s implementation of the user fee agreements for the prescription drug, 

medical device, generic, and biosimilars industry signed into law 

last year. In New Jersey alone the life sciences support over 

300,000 direct and indirect jobs and contributes more than $25 billion to the State’s economy. 

Historically the user fee agreements have improved the times of 

drug and devices, and today’s hearing will help this committee gain 

further insight on how the FDA is carrying out these congressionally mandated responsibilities. It is important that regardless of 

the challenges the agency faces it remain committed to bringing innovative treatments to market and in the hands of patients who 

need them the most. 

Thank you, Mr. Chairman. I look forward to hearing from our 

distinguished witnesses, Dr. Woodcock and Dr. Shuren, on these 

issues. And I yield back to you, sir. 

Mr. PITTS. The Chair thanks the gentleman. 

Now yields 5 minutes to the ranking member, Mr. Pallone, for 

an opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Chairman Pitts. 

And thank you to our witnesses for being here today. I am eager 

to hear your testimony about FDA’s progress in implementing the 

Food and Drug Administration Safety and Innovation Act, or 

FDASIA. 

Over 1 year ago, FDASIA was signed into law and, among other 

things, was designed to promote timely FDA review of drugs, medVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
4 

ical devices, generic drugs, and biosimilar biological products 

through the collection of user fees. It both renewed existing FDA 

user fee programs for pharmaceutical and medical device manufacturers and established new user fee programs for generic drugs and 

for lower cost versions of biotech drugs. 

The user fees are an essential component of FDA’s funding. They 

help to ensure a predictable and efficient review process so that the 

American public has access to safe and effective healthcare products. 

For generics, at the time of enactment there was a backlog of 

over 2,500 applications for new generic drugs and a median review 

time of 31 months. These essential products typically cost 50 to 70 

percent less than their brand name counterparts and have provided 

an estimated $1 trillion in savings to the Nation’s healthcare system over the past decade. It is important that American consumers 

have access to these safe, effective, and low cost alternatives more 

quickly, which is why the provisions in the generic drug user fee 

agreement were so important, because it gave FDA the resources 

they need to make sure that happens. So I am interested to hear 

in that progress today. 

FDASIA also gives FDA additional tools to ensure the safety of 

the global drug supply chain, such as requiring registration with 

the unique facility identifier for foreign and domestic drug establishments, administrative detention for adulterated or misbranded 

drugs, and increased penalties for counterfeit drugs. The additional 

authorities in FDASIA allow FDA to strengthen cooperation with 

foreign regulators as well. 

These provisions were based on the ideas and proposals contained in the Drug Safety Enhancement Act, which I introduced 

with Mr. Dingell, Mr. Waxman, and Ms. DeGette. We worked hard 

with our Republican colleagues during consideration of this law to 

help FDA keep our medicines safer in this complex and ever-growing global supply chain. 

We also included provisions in FDASIA to address drug shortages. FDASIA enhances early notification of supply interruptions 

for certain medically important drugs and directs FDA to establish 

a task force and submit a strategic plan on drug shortage mitigation, which FDA submitted to Congress last month. Early notification started as a result of an executive order in 2011 and was codified into law by FDASIA, and it has helped FDA to prevent shortages and to decrease the number of new shortages. 

I will close by saying that FDASIA is the product of strong bipartisan collaboration and compromise that strengthens FDA’s ability 

to safeguard the public health. What I outlined here today was only 

a snapshot of the promising provisions of the law. We strengthened 

both the agency and the public health by its passage while allowing 

companies to innovate in the process. And I am proud of the work 

we did in passing FDASIA, and I look forward to hearing about 

FDA’s progress so far in implementing this law. 

So I would like to yield the remainder of my time to Mr. Dingell. 

5 

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. I thank my good friend for that. 

This legislation is a fine example of the great work this committee can do when we put politics aside and work together in a 

bipartisan manner. I hope the committee will return to this spirit 

when considering a lot of other issues that will lie before us today 

and in following times. 

One year ago, President Obama signed the Food and Drug Administration Safety and Innovation Act into law, the law [audio 

gap] user fee programs FAD. Big bold steps to improve supply 

chain safety, amongst other things. FDA now needs new innovative 

tools to deal with increasingly globalized supply chain [audio gap] 

succeed in their mission keeping the American people safe from 

harm from food, drugs, cosmetics, and other things. 

I look forward to hearing from our witnesses today about the 

progress made by FDA and I commend you for having this hearing, 

and look forward to hearing from Food and Drug about what it is 

they are doing, how the matter is proceeding and how much more 

this committee must do to see to it that they are able to carry out 

their responsibilities. 

Dr. Woodcock, welcome. 

I yield back to my good friend Mr. Pallone the time that he so 

graciously yielded to me. 

Mr. PALLONE. I yield back the balance of my time. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the chair of the full committee, Mr. Upton, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you again, Mr. Chairman. And I appreciate this morning’s hearing on the implementation of the FDA 

Safety and Innovation Act. 

You know, as many of us know, this was one of the committee’s 

most significant bipartisan achievements in the last Congress, it 

really was. I particularly want to thank Dr. Woodcock, who is with 

us, and Dr. Shuren for coming today to provide an update on that 

implementation, something that we said we would do when it 

passed. 

Last Congress this committee held at least 10 hearings on subjects related to the legislation, and at these hearings we focused on 

improving the predictability, consistency, and transparency of 

FDA’s regulations of drugs and medical devices. Improving FDA 

regs is essential to fostering innovation which brings life-saving 

and life-improving drugs and medical devices to American patients 

and boosts job creation across the country, including southwest 

Michigan, most importantly. 

I was very proud of the bipartisan work that we did in the last 

Congress, and I am pleased to hear that initial reports on implementation, especially at the Drug Center, are promising. Today is 

an opportunity to get an update on whether the FDA is meeting 

6 

its commitments related to the various user fees that we authorized, as well as the independent assessment of the device center. 

It also is a chance to hear about how the FDA is implementing 

provisions related to rare diseases, drug shortages, an important 

provision that we wrote in, prescription drug abuse, and drug imports. These were provisions important to Republicans and Democrats, Americans across the country, and we look forward to working with the FDA on these issues. Our drug and device makers are 

global leaders in innovation and job growth, and we will continue 

working to ensure that they remain on top. 

And I am prepared to yield to any of my Republican colleagues. 

Seeing none, I yield back the balance of my time. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Mr. Chairman, thank you for holding today’s hearing on the implementation of 

the Food and Drug Administration Safety and Innovation Act. As many of you 

know, this was one of the committee’s significant bipartisan achievements last Congress, and I thank Dr. Woodcock and Dr. Shuren for coming today to provide an 

update on implementation. 

Last Congress, the committee held at least 10 hearings on subjects related to 

thelegislation. At these hearings, we focused on improving the predictability, consistency and transparency of FDA’s regulation of drugs and medical devices. Improving FDA regulation is essential to fostering innovation, which brings lifesaving, lifeimproving drugs and medical devices to American patients and boosts job creation 

across the country, including southwest Michigan. 

I am very proud of the bipartisan work we did last Congress, and I am pleased 

to hear that initial reports on implementation, especially at the Drug Center, are 

promising. 

Today is an opportunity to get an update on whether FDA is meeting its commitments related to the various user fees we reauthorized, as well as the independent 

assessment of the device center. It also is a chance to hear about how FDA is implementing provisions related to rare diseases, drug shortages, prescription drug abuse, 

and drug imports. These were provisions important to Republicans and Democrats, 

and we look forward to working with FDA on these issues. Our drug and device 

makers are global leaders in innovation and job growth, and we will continue working to ensure that they remain on top. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the ranking member of the full committee, Mr. 

Waxman, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Mr. Chairman. I am pleased we are 

holding this oversight hearing on the legislation that we passed 

last year on a bipartisan basis, bipartisan, bicameral, and with the 

close working relationship with the Food and Drug Administration. 

The bill had a number of important provisions. It reauthorized 

FDA’s drug and medical device user fees programs, providing resources to enable the efficient review of applications and give patients access rapidly to new therapies. It reauthorized two pediatric 

programs which foster the development and safe use of prescription 

for children. Established two new user fee programs to help FDA 

speed up the review of new generics and biosimilars. It gave FDA 

new authorities to address a wide array of issues with respect to 

drugs and devices, new incentives for the development of antiVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
7 

biotics to treat serious and life-threatening infections. This was designed to ensure that the drugs we most need to protect us from 

dangerous resistant pathogens are the ones that are developed as 

quickly as possible. 

This law also includes provisions to modernize FDA’s authorities 

with respect to our increasingly globalized drug supply chain. 

Today 80 percent of the active ingredients in bulk chemicals used 

in U.S. drugs come from abroad and 40 percent of finished drugs 

are manufactured abroad. This law gave FDA new and improved 

tools to police today’s dramatically different marketplace. The legislation addressed the crisis of drug shortages that has caused many 

problems for access to medicines in our country. 

There are provisions relating to medical devices. I had some concerns about many of the device proposals, but we worked together 

to address these concerns with the goal of assuring that nothing in 

the House-passed bill took us backwards in terms of patient safety. 

And I hope Dr. Shuren will tell us today whether we succeeded in 

that goal or if there have been unintended and detrimental facts 

of this legislation. 

Mr. Chairman, I thank you for holding this hearing. It is an important part of the job of Congress not just to work together to pass 

legislation, but to continue our review and oversight. I hope FDA 

will share with us whether there are any refinements or improvements to any of the law’s provisions that we need to pass through 

the Congress. Our goal was and still is to ensure that the American 

public benefits from this legislation by getting access to safe and 

effective drugs and medical devices at the earliest possible time. I 

look forward to the testimony. 

I do notice that I do have a couple of minutes left and if any 

member on our side of the aisle wants that time I would be happy 

to yield to them. And if not, I will offer the time to anybody on the 

other side of the aisle who wants to make any further comments. 

If not, I yield back the time. 

Mr. PITTS. The gentleman yields back. Chair thanks the gentleman. 

That concludes the opening statements. 

On our panel today we have two witnesses from the U.S. Food 

and Drug Administration, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, and Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health. 

Thank you for coming. Your written testimony will be made a 

part of the record. We ask that you summarize your opening statements to 5 minutes. And at this time the Chair recognizes Dr. 

Woodcock for 5 minutes for an opening statement. 

STATEMENTS OF JANET WOODCOCK, DIRECTOR, CENTER FOR 

DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION; AND JEFFREY E. SHUREN, DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND 

DRUG ADMINISTRATION 

STATEMENT OF JANET WOODCOCK 

Ms. WOODCOCK. Thank you and good morning. I am Janet 

Woodcock, head of the center for drugs at FDA. 

8 

The FDASIA legislation was really landmark legislation for drug 

regulation. It authorized two new user fee programs, one of which 

was critically needed to fix a problem, the problem of the backlog 

of generic drugs, a program that had become burdened by its own 

success and the massive filing of new generic drug applications 

that we had. And another one, which is more or less preventive, 

the biosimilars user fee program, hopefully will help us promptly 

review biosimilar drugs and get them on the market as we receive 

applications. 

It also made two pediatric pieces of legislation permanent. And 

I am happy to say we passed a landmark of 500 labels that have 

been revised and updated with pediatric information because of 

this legislation. So 500 drug labels have information now for children that didn’t before. 

Additional pressing problems that were addressed included the 

lack of new pipeline for antibiotics, particularly for drug-resistant 

organisms, the drug shortage problem, and the supply chain safety 

issues. In addition, the legislation included a breakthrough designation program that has been very enthusiastically taken up, 

both by the industry and by the FDA, and many other provisions 

of course. 

Congress laid out a very ambitious agenda and timeframe for our 

accomplishment of all of this, and we have been working hard, we 

have been very successful in implementing provisions. However, I 

brought our spreadsheet. This is two-sided, OK, tracking of all the 

obligations that we have under this legislation. And this isn’t all 

of them, but it is certainly the ones that have hard deadlines. So 

we are trying to work against all these deadlines and make all of 

our timeframes and so forth. 

I am happy to discuss this year’s progress with you, and I look 

forward to working with the committee. Thank you. 

Mr. PITTS. The Chair thanks the gentlelady. 

Dr. Shuren, you are recognized 5 minutes for an opening statement. 

STATEMENT OF JEFFREY E. SHUREN 

Mr. SHUREN. Thank you. Mr. Chairman and members of the subcommittee, I am Dr. Jeff Shuren, Director, Center for Devices and 

Radiological Health, or CDRH, at the Food and Drug Administration. 

FDASIA includes a third authorization of the Medical Device 

User Fee Act, or MDUFA III. Reauthorization of the medical device 

user fee program has helped to speed innovative new products to 

market without compromising safety and effectiveness. It did so by 

establishing new policies, procedures, and performance goals, and 

by boosting review capacity. It represents our commitment to increase the predictability, consistency, and clarity of our regulatory 

processes. 

In exchange for the additional user fees, we work with stakeholders to develop much enhanced performance goals. We are committed to meeting those goals, and preliminary data indicates that 

we are on track to meet or exceed all of our fiscal year 2013 performance goals, and that includes a new shared goal with industry 

of average time to decision. 

9 

Since the early 2000s, CDRH’s performance on several key measures had been steadily declining each year, reaching its lowest 

point in 2010. In 2010 we conducted an extensive assessment of 

our premarket programs, identified the problems, proposed solutions, sought extensive public input, and then issued a plan of action in January 2011, with some corrective action starting in 2010. 

Since 2010, due to the reforms we put in place in MDUFA III, we 

have seen improvement in these key measures. For example, our 

backlogs of 510(k) submissions and PMA applications are each 

down by about one-third. Our average total time to decision of 

PMA applications is down 37 percent. The percent of 510(k)s 

cleared and percent of PMAs approved are back up, in the case of 

PMAs back to where it was about a decade ago. 

To provide greater transparency we are would providing substantially more detailed reporting on our progress in implementing performance goals. These reports are publicly available online and are 

discussed at quarterly meetings with industry. 

FDASIA also includes provisions to streamline the de novo pathway for novel devices of low to moderate risk. Since passage of 

FDASIA, we have seen the number of de novo requests roughly 

double. We have also implemented process improvements and are 

seeing our review times for de novos trending downward as a result. As part of our MDUFA III commitments we agreed to implement our benefit-risk determination guidance we issued in March 

2012. For the very first time and with public input we described 

the factors we would use in determining whether or not the benefits of the device outweigh its risk. 

The framework we developed is flexible and patient-centric. For 

example, one factor we may take into account is patients’ tolerance 

for risk and perspectives on benefits. Because patient viewpoints 

matter and to further implementation of the framework, earlier 

this year we launched our Patient Preferences Initiative. The initiative seeks to identify and validate tools for assessing patient 

preferences, establish an approach when incorporating those preferences into our device approval decisions, and then communicating that information publicly so that patients and practitioners can make better-informed decisions. 

CDRH implemented the FDASIA provisions relating to investigational device exemptions, or IDEs. We have trained our staff and 

modified our decision letters to align them with FDASIA’s requirement that FDA may not disapprove the clinical investigation on the 

basis that it would not support approving the device. 

We have also taken several steps to facilitate first-in-human 

studies in the U.S. and to streamline our clinical trials program. 

As a result, the mean time for giving approval for manufactures to 

proceed with clinical studies of their devices has been cut almost 

in half. 

We also recently announced a final rule for unique device identification, or UDI system, which will provide a standardized way to 

identify medical devices. The UDI reflects substantial input from 

the clinical community and from the device industry during all 

phases of its development. Once fully implemented the UDI system 

will provide improved visibility for devices as they move through 

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ing our post-market surveillance capabilities and offering a way of 

documenting device use in electronic health records. We have also 

made good progress on classifying the remaining pre-amendment 

devices. Since passage of FDASIA we have issued 13 proposed orders. 

Implementing the device-related provisions of FDASIA is a massive undertaking, but we are committed to doing it in a way that 

provides lasting improvement to public health. Mr. Chairman, I 

commend the subcommittee’s efforts and am pleased to answer any 

questions. 

[The prepared statement of Ms. Woodcock and Mr. Shuren follows:] 

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Mr. PITTS. The Chair thanks the gentleman. That concludes the 

opening statements. We will now begin questioning. I will recognize 

myself 5 minutes. 

Before I begin, Dr. Woodcock, would you submit that spreadsheet 

for the record? 

Ms. WOODCOCK. I will confer with my folks and see what I can 

send you. We definitely will give you something. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. All right. And I have a number of questions for both 

of you that I will submit for the record. Would appreciate that you 

respond promptly. 

Dr. Woodcock, we enacted FDASIA in order to bring greater predictability, consistency, and transparency to FDA’s regulation of 

medical devices and drugs. FDASIA included some significant 

changes to the review process on the device and drug side. How 

have you translated the FDASIA policy changes into the regulatory 

review process? And how have you communicated these changes to 

your staff? How are you ensuring that your staff implements the 

law correctly? 

Dr. Woodcock, you want to begin? 

Ms. WOODCOCK. Well, some of the primary changes that we received, we negotiated with the industry under the PDUFA agreements for a new review program for new molecular entities. They 

are the most innovative drugs. We are now having midcycle meetings during the review process. So this mainly changes how we run 

the review process, allows for more communication between industry and the review staff during the review process. And it is hoped 

we can clear up any confusion, answer questions and so forth, and 

get to a complete response that includes all the issues at the end 

of the day. 

So we are running that as a pilot. We are going have an independent assessment of that. We have had a number of new molecular entities that have been approved. I believe six have been approved that have gone through that program. So it is in its early 

stages, though, because we are going to run several years of the 

program and then evaluate its success. 

And the other major change, of course, has been the breakthrough designation program, and I could talk about that if you 

want. So we have received almost up to 100 applications for designation under this program. We have designated more than 25 different products for a range of different diseases as potential breakthrough products. And we have just approved two, one last week 

and one on Wednesday. On Wednesday we approved a drug for 

mantle cell lymphoma, which is a rare kind of immune system or 

blood tumor. 

So we feel this program has been fairly successful so far in bringing greater attention to drugs that are potential game changers for 

people with serious diseases. 

Mr. PITTS. All right. Thank you. 

Dr. Shuren, under MDUFA III industry and the FDA agreed to 

have an independent two-phase assessment and program evaluation to objectively assess the FDA’s premarket review process. Can 

you explain how FDA was involved in setting the parameters of 

this assessment? 

36 

Mr. SHUREN. Certainly. We have put out calls for an independent 

contractor to perform the work, and that was assigned to—oh, my 

apologies. 

We have put out a call to have an independent contractor perform the assessment, and Booz Allen Hamilton is that contractor. 

We worked on a draft statement of work which we put out to the 

public for comment. We had discussions with industry on what 

should go into that statement of work. 

And then finally we have been overseeing the process for the contractor. We get updates on the progress they make. But it is independent, so we don’t know what they are actually going to report 

to us. Our understanding is they have gone out, they have had conversations with stakeholders, particularly industry, they have conducted focus groups. And we are expecting to get their first report 

very soon, and we have a public commitment to make that available to the public in December, which we will do. And that first 

phase includes their at this point preliminary findings, a lot of 

their more of the low-hanging fruit. Six months thereafter, so in 

May, they will have the second phase, where we will get all of their 

recommendations. At that point, too, we have a public commitment 

to issue our plan for implementation of the recommendations. 

Mr. PITTS. Would you agree to submit a detailed accounting of 

the agency’s involvement with the contractor relating to the review 

and any recommendations or directions you provided them? 

Mr. SHUREN. Yes, we can provide you with information. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. And would you agree to submit a compiled list of recommendations in its entirety to the committee upon its completion? 

Mr. SHUREN. We are going to make it available to the entire public. 

Mr. PITTS. OK. 

Mr. SHUREN. But we will include you on that, too. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. All right. 

Dr. Woodcock, the President’s Council of Advisors on Science and 

Technology’s September 12th report included specific recommendations on how the Federal Government might propel innovation in 

drug discovery and development. PCAST expressly recommended, 

quote, ‘‘It could be valuable for the Congress to establish that encouraging innovation and drug development is a clear component 

of the FDA mission,’’ end quote. 

Do you agree with the President’s advisors that including innovation in the mission statement would be valuable? 

Ms. WOODCOCK. Well, I think it is a double-edged sword. We 

don’t encourage innovation for innovation’s sake. OK? Innovation 

can end up being bad as well as being good, right? But innovation 

is essential to treat current unmet medical needs. So absolutely we 

should foster innovation and be open to it and allow new methods 

of both treating patients and manufacturing drugs to have 

progress. So I think it is really how you state that support for innovation that is important. 

Mr. PITTS. All right. My time has expired. 

The Chair recognize the ranking member, Mr. Pallone, 5 minutes 

for questions. 

37 

Mr. PALLONE. Thank you, Mr. Chairman. 

My questions of Dr. Woodcock—first, welcome back. I can guess 

you have had quite a busy year. And I wanted to start today talking about the new Office of Generic Drugs. I was glad to see the 

decision FDA made last year to elevate the Office of Generic Drugs 

to a ‘‘super office’’ on equal footing with the Office of New Drugs 

within the agency. And as you know, I introduced a bill last year 

that included a provision to do just that and I have long been an 

advocate for the structural change within FDA to enhance the role 

of the Office of Generic Drugs. 

I would like to ask you, Dr. Woodcock, whether the Office of Generic Drugs has officially been set up in its new elevated position? 

And how is it structured? What kinds of changes have been made? 

And when do you expect the change to be finalized? 

Ms. WOODCOCK. The organizational change has been not finalized. We are in the final stages of that, and I hope it would occur 

very soon. What it will do is recognize the fact that generic medicines treat most people in the United States. Eighty-four percent 

of dispensed prescriptions are for generic drugs. And so the new generic drug office will have a much more clinical focus. We will have 

more doctors there, more clinical staff, very much focused on therapeutic equivalents, the adverse event reporting, making sure those 

generic drug labels are up to date and so forth. 

So as a super office it is proposed to have a bioequivalence office, 

a research office, because under GDUFA we negotiated and received money so that we can do research to get new categories of 

drugs like inhalers to become generics, right? So they have a research office and then an office that will run the operations, including a clinical safety staff. 

Now, as part of this, what we are proposing, though, is that quality regulation, drug quality regulation be reorganized and that we 

centralize that, and that is a plan that I am working very intimately on. And this would ensure that generic drugs, new drugs, 

over-the-counter drugs, any kind of drug we regulate have the 

exact same quality expectations across the industry. 

Mr. PALLONE. OK. Then I wanted to speak about the FDA’s 

progress in implementing GDUFA. I commend the FDA on meeting 

its GDUFA hiring goals for the fiscal year, and I know the difficulties associated with implementing a brand-new program. But how 

many FTEs have you hired to date and how many do you plan to 

hire in the first two quarters of next year? And given the backlog 

of pending ANDAs, can you give the committee an estimate on how 

many of these new hires will be dedicated to ANDA review? I have 

others, but let’s start with that. 

Ms. WOODCOCK. OK. We have hired upward of 300 people. I 

mean, that number changes every day. We are aggressively hiring. 

And we exceeded our GDUFA goal, which was 25 percent of the 

total number of people that were to be hired. OK? 

We have acted on 900, I think, of ANDAs in the backlog in different ways, so we have reduced that pending backlog, but it is still 

formidable. I wouldn’t diminish that. And we have done a lot of 

things to try and aggressively address this backlog. So your other 

question? 

38 

Mr. PALLONE. Well, I was going to ask you if the government 

shutdown affected the progress for those 2 or 3 weeks? 

Ms. WOODCOCK. Well, the major effect on our review programs, 

because we were able to continue to operate under the user fees. 

However, the inspections stopped for those several weeks. So the 

inspectional programs were not operating. And of course that is one 

of the things that we really need to ramp up under GDUFA, is to 

increase the number of facility inspections that we do if we are 

going to tackle this backlog and get into a steady state. 

Mr. PALLONE. And the last thing, it is my understanding that 

FDA recently advised sponsors that it has restricted communications with sponsors during the ANDA process. Specifically, rather 

than providing ongoing status updates, the FDA has a new policy 

of only providing approval answers. Can you explain the reasoning 

behind this, why you feel the need to have less communications 

than before, given that we have the user fee funds available? 

Ms. WOODCOCK. We have upward of 8,000 items pending in the 

generic drug review program. The previous practice was companies 

would call all over the place to try to find their status. If every 

chemist and bioequivalence reviewer is answering questions from 

8,000 different sites asking them what is the status, we are never 

going to get done. 

So we are trying to bring order to this process, like we have for 

PDUFA, and what we want to do is have predictable deadlines so 

that every company knows their application is on track and going 

to get out of the agency and they are going to get a complete response within the timeframe that has been established under 

GDUFA. 

So I think some of this is a transition issue where we are going 

from one state to another and we are going to have to get through 

this period. We are doing everything we can and we are considering additional steps to notify industry as their application approaches an action so that they can prepare, say, for launch or 

whatever they need to prepare for. We understand that need. However, we can’t have companies’ thousands of calls to reviewers or 

we are not going to get this program done. 

Mr. PALLONE. All right, thanks a lot. 

Mr. PITTS. The Chair thanks the gentleman. 

We are presently voting on the floor. We will try to get through 

a couple more members. The Chair recognize Mr. Whitfield for 5 

minutes for questions. 

Mr. WHITFIELD. Well, thank you very much, and thank you all 

for joining us this morning. 

Last April I attended a meeting with a group of dermatologists 

and they were talking about the approval process for over-thecounter in general and sunscreen in particular. And they had indicated that there were, like, eight sunscreen applications that had 

been at FDA waiting for a decision for, like, 10 years. Some of 

these have been used in Europe. 

We all are very much aware that you all have a very heavy 

workload and you have limited resources. And I know in conversations with Congressman Dingell, and I know on the Senate side 

Senators Reid and Isakson have been discussing this issue, and 

Congressman Dingell and I have draft legislation to try to expedite 

39 

the process and we had submitted to you all for technical assistance. And I was going to ask, one, are you, with the multitude of 

issues you deal with, are you even aware of legislation that we 

have submitted? And if you are, could you give us any idea of 

maybe when we could expect a response from you? 

Ms. WOODCOCK. We hope you would get a prompt response. 

Mr. WHITFIELD. OK. 

Ms. WOODCOCK. This is a very intractable problem. I think, if 

possible, we are more frustrated than the manufacturers and you 

all are about this situation. We have to do regulations to get these 

ingredients into the monographs. That is the problem. And they 

are backlogged and they are slow to get through, and we have to 

do a proposed regulation, sometimes we have to do advanced notice 

of proposed regulation, then do a proposed rule, and then do a final 

rule, which can take 6 to 8 years. And we have multiple categories 

of these over-the-counter products that we have to handle. But the 

sunscreens, there is a public health issue here. 

Mr. WHITFIELD. Right. And who on your staff specifically can we 

be in contact with on the technical assistance? 

Ms. WOODCOCK. Well, I think that our lead in this is Dr. Sandra 

Kweder, who is acting head right now of the office that oversees 

this, but, of course, work through our legislative staff and we will 

provide any assistance needed. 

Mr. WHITFIELD. OK. 

Mr. DINGELL. Would the gentleman yield? 

Mr. WHITFIELD. I would be happy to yield. 

Mr. DINGELL. Briefly. First of all, I want to thank the gentleman. 

Second of all, I want to commend him. And third of all, I want to 

note that this is important. This matter has been dawdling by prodigious overlong delay, and it has simply got to come to a halt. 

Your assistance would be extremely important. I want to work with 

my good friend. And I urge you to resolve this problem. It is a significant problem that does do the Food and Drug Administration no 

credit whatsoever. 

Mr. WHITFIELD. I yield back the balance of my time. 

Mr. PITTS. The Chair thanks the gentleman. 

I think we can get one more in. We will reconvene shortly after 

the second vote. There are two votes. That will be about 11 o’clock. 

The Chair recognize the gentleman, Mr. Dingell, 5 minutes for 

questions. 

Mr. DINGELL. Mr. Chairman, I would like to defer. I move rather 

slowly. 

Mr. PITTS. All right. Then we will at this point recess the committee until after the second vote, and hope you will be patient 

with us. We will get back as soon as we can. Thank you. The committee is in recess. 

[Recess.] 

Mr. PITTS. The time for our recess having expired, the subcommittee will reconvene. And the Chair recognize the gentleman 

from Texas, Mr. Green, for 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman, for holding the hearing. 

And, Dr. Woodcock and Dr. Shuren, thank you for taking time 

to be here today. 

40 

One of my top priorities is fostering a regulatory environment 

that would promote the development of the new antibiotic drugs to 

address the growing public health threat of drug-resistant bacteria. 

I am proud to have worked with leaders on this committee, Dr. 

Gingrey and a coalition of other members, to advance the GAIN 

Act last year. We have always said that this was a good first step, 

but more must be done. And I know from your testimony today 

that is true. Thank you for your leadership on the GAIN Act, Dr. 

Woodcock, and also promoting the new antibiotic development. 

In April, CDC released a report on drug-resistant bacteria. In 

that report, CDC states that antimicrobial resistance is one of the 

most serious health threats to our country. Dr. Woodcock, does the 

FDA agree with the CDC on the nature of this threat? 

Ms. WOODCOCK. Absolutely. We are very concerned about this. 

Mr. GREEN. In this report, the CDC highlights a handful of strategies to address this threat. One of the main methods they suggested was to develop new antibiotics. As I understand it, part of 

the challenge of the new developing antibiotics is that drug resistance oftentimes begins in limited populations and approving a drug 

through the FDA for use in a limited population can be difficult. 

Dr. Woodcock, on June 4th of this year you were quoted by the 

National Public Radio as saying that you hope Congress would 

pass legislation soon to make it easier for FDA to approve new 

antibiotics. What type of legislation were you referring to when you 

made those statements on NPR? 

Ms. WOODCOCK. Well, there have been discussions, and the 

PCAST report referred to earlier—I am sorry. There have been discussions, and the PCAST report referred to earlier have talked 

about a program for limited use that is specifically directed where 

there is subpopulation of broader population. Because one of the 

problems we have with the antibiotics, as you well know, is overuse. And what we are concerned about if we approve an antibiotic 

for a limited use, just for drug-resistant organisms, that there 

would be temptation to use it more broadly and thus lose its effectiveness. And so we feel that it should be explored that Congress 

could make some kind of program that would really send a signal 

about limited use and then good antibiotic stewardship. 

Mr. GREEN. Well, I am working on legislation with my colleague 

Dr. Gingrey, and meant to be the next step from GAIN, focused 

primarily on promoting antibiotics meant to be used in limited populations. Is there anything that you believe we should keep in mind 

as we draft this legislation? 

Ms. WOODCOCK. Well, I feel that a strong signal from Congress 

to the healthcare community about stewardship would be extremely important. FDA frequently approves drugs for limited populations, but usually there isn’t that sort of, let’s say, an orphan 

population, there isn’t that sort of temptation or ability to use it 

broadly in a much broader population. 

So one of the main things is a signal from Congress that it is fine 

to do limited populations out of a broader disease with a very small 

development program, but then there should be that stewardship 

by the healthcare community to not use it more broadly. 

Mr. GREEN. Well, and I know if you deal with any of the infectious disease specialties, they talk about that. And can we statuVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
41 

torily, because I know in medical practice a doctor can make that 

decision on their own, and that may be part of the problem. But 

you can’t limit it to just, for example, people who deal with infectious diseases, I guess. 

Ms. WOODCOCK. We feel that there shouldn’t be an overt limitation like that, because it is not feasible. Patients come in, they 

have infections, there is a resistant strain circulating in the community, doctors should have the discretion to use appropriate antibiotics. However, I think a signal of prudence and stewardship 

would be a mechanism I think would be very effective. 

Mr. GREEN. And I am almost out of time, but the other issue on 

that is we need to make sure we keep this, because what may be 

successful a year from now or 10 years from now, we will still have 

people who develop those resistance, so we need to keep that pipeline going for these new levels of antibiotics and other ways to 

treat these terrible illnesses. 

As health care gets more advanced and threats to our health get 

more complicated, it is important that both Congress and the FDA 

be responsive to this changing world. Many of the processes at 

FDA are decades old. Drug resistance, medical software, and personalized medicine are going to strain the limits of the outdated 

statute. I hope we can work together and have FDA as an active 

partner when we are drafting this and protect not only public 

health, but foster that innovation we need for that long term. 

So, Mr. Chairman, thank you for your time. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the vice chair of the committee, Dr. Burgess, for 

5 minutes for questions. 

Mr. BURGESS. Thank you, Mr. Chairman. I apologize I wasn’t 

here earlier. I had some obligations on the House floor. 

I do want to take this opportunity just to recognize the fact that 

this subcommittee, and in fact the Energy and Commerce Committee as a full committee, did its work in what was sometimes a 

very difficult election year of 2012. Food and Drug Administration 

reauthorization of user fee agreements was going to expire. All of 

the people who write in the important papers around town said we 

couldn’t do it. And you and Mr. Upton did it. The bill went through 

regular order, passed the subcommittee, passed the full committee, 

went over to the Senate, conference with the Senate, and the President signed it into law on July 9th of 2012. No one knows that because there was no signing ceremony and there was no press 

present. But Congress, when pressed, can actually function in a 

very reasonable way. 

Dr. Woodcock, as you will recall, during the reauthorization discussion, actually I worked with Ranking Member Pallone on the 

concept of the advisory committees to make certain that they were 

staffed with the very best experts to serve patients well, serve you 

and your agency well, and reduce backlogs and save resources. And 

so it looks to me like the initial thing, reports I am getting are 

good. Do you have any updates for the committee today? 

Ms. WOODCOCK. Yes. We have been able to remove several steps 

that were very time consuming within the vetting of the advisory 

committee process for members for a specific committee. That has 

helped us streamline that program. Of course, all advisory comVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
42 

mittee members are still subject to the broad Federal conflict of interest requirements, and that is, you know, fairly stringent as well. 

But the additional steps have been removed, and that has been 

helpful. 

Mr. BURGESS. And sometimes it is helpful to have someone on an 

advisory committee who actually has some knowledge of the 

pathophysiology that might be involved in the disease under which 

we are contemplating treatment? Would that be a fair statement? 

Ms. WOODCOCK. I would say it is essential. 

Mr. BURGESS. I think so, too. 

Now, there is going to be a rare disease meeting in January of 

this year. Is that correct? 

Ms. WOODCOCK. I believe so. 

Mr. BURGESS. And looking forward to improving the regulatory 

process for approving drugs for rare diseases. You held a similar 

meeting in 2010 and issued a report with recommendations. Can 

you kind of update us as to the implementations of those recommendations made 3 years ago in advance of this next meeting 

in January? 

Ms. WOODCOCK. Well, I think we are doing extremely well on 

rare diseases. We have established a rare disease staff. We are 

tracking all the rare diseases. In 2013 we approved a large number 

of products for rare diseases. Every one of them was approved 

based on a surrogate in fiscal year 2013. That is 1, 2, 3, 4, 5, 6, 

7, 8, 9, 10, 11, 12 were products for rare diseases. And then one 

was approved on an animal rule without human efficacy testing. So 

we do have a robust program, and we are going to try to take it 

to the next level as we have more meetings, public meetings. 

Mr. BURGESS. Dr. Shuren, as you know, for some time I have 

been interested in the research use only application. And there is 

recent guidance put out by your department that only products 

that could significantly restrict patient access and restricting sales 

of these products. Is there any evidence out there of patients being 

harmed by research use only products? 

Mr. SHUREN. Well, we do have evidence of companies who are 

putting those products out for research use only, but actually promoting them for clinical diagnosis in cases where those research 

use only, because they are research use only, haven’t been shown 

necessarily to be accurate. And in times where we have taken action, it is predominantly where there is an already available approved or cleared test that would be there as an alternative. 

We have recognized some of the concerns, I will tell you, with the 

guidance. And one of the things in there was about putting on the 

makers of research use only that they should reasonably know 

about the people they are selling it to and their intentions. That 

is something we heard loud and clear. I want too tell you we have 

heard those comments. That will come out of the final guidance. 

And that final guidance will come out probably by the end of this 

month, and we will get you a copy of that, too. 

Mr. BURGESS. And I appreciate that. But specifically, do you 

have evidence that patients have been harmed by using the research use only designation? 

Mr. SHUREN. I am not aware of a specific patient for one of those. 

I don’t know. We can look a little bit further. 

43 

Mr. BURGESS. Thank you. And I would appreciate your further 

investigation of that. 

Finally, Dr. Woodcock, I just have to ask a question. January 1st 

of 2012 I lost access to a low-cost over-the-counter asthma inhaler. 

When am I going to get it back? 

Ms. WOODCOCK. Well, I can’t talk, as you know, publicly about 

applications that might be pending and so forth. But certainly that 

monograph status remains. And we certainly heard your concern. 

Mr. BURGESS. Thank you. 

Mr. PITTS. The Chair thanks the gentleman. 

And now recognize the gentlelady, Ms. Castor, for 5 minutes for 

questions. 

Ms. CASTOR. Well, thank you, Mr. Chairman. 

And welcome. Dr. Woodcock, in September, in Tampa we had the 

BioFlorida Conference with researchers and device manufacturers 

and folks that are developing drugs come from all across the State. 

And FDA was kind enough to send Dr. Richard—— 

Ms. WOODCOCK. Moscicki. 

Ms. CASTOR. Moscicki, thank you, from the Center for Drug Evaluation and Research. And I want to thank you very much, because 

it is, I know, the budgets are very tight, but to have folks that are 

leaders at FDA be able to interact directly with the folks in my 

State was greatly appreciated. So thank you. And the conference 

focused a lot on the future of drug approvals. 

So we are pleased that the Federal laws are working well. I 

think the number one fear of everyone, the topic of this conference 

turned to sequestration, because people are rather surprised that 

even though FDA relies a lot on user fees, the user fees are subject 

to sequestration. This is not smart. 

Some of the analysis I have seen, and tell me if these numbers 

are right, that to your budget, I don’t know if this is the entire 

FDA budget or just your section, that in fiscal year 2013 you were 

subject to sequestration of $209 million. And on top of that, $85 

million in private funding, the user fees, were sequestered at the 

same time. And then in fiscal year 2014, if the sequester is not replaced, you are looking at a cut of $319 million. And $112 million 

of that, or you can explain that, on top of that or as part of that 

is the private funding user fees. 

I mean, this has got to have a harsh impact on development of 

new therapies, on review of devices, on review of innovative drugs. 

Tell us what you are facing now in your shop. 

Ms. WOODCOCK. Well, the sequestration has been very difficult. 

Of course, it cuts the appropriated support for these programs as 

well as where there are use fees, some of the user fee programs 

have been subject. My understanding is that total for user fees has 

been $79 million in the last fiscal year. But, frankly, how these are 

calculated is above my pay grade, all right? But what certainly has 

happened, there are user fees that we are not able to access, across 

the device and the PDUFA program, and that would continue. 

And what happened with PDUFA, we negotiated and the bill was 

passed. It recognized the new agreements on rare diseases, patientfocused drug development, and these other programs. And then the 

sequester removed practically the whole amount that was negoVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
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tiated for these new programs, these patient-focused programs, and 

other programs. 

Now, we have put on the patient-focused drug development meetings regardless, but our implementation of our rare disease staff 

has been delayed because of the sequester, and similarly with a 

number of the other programs that we agreed to. 

Ms. CASTOR. So that is not good news for families across the 

country, families with rare diseases that rely on your agency. It 

seems like we have taken a step forward with the Federal laws 

that have given you certain authorities and expanded user fees, but 

then it seems like on the other hand sequestration, brought by the 

Congress, is going to handicap you. I mean, this is a bad time to 

shortchange FDA. Can you characterize what it means, where you 

are very concerned? And I would assume you would recommend 

that sequestration be replaced going forward. 

Ms. WOODCOCK. Well, as I said, the whole financial issues are 

above my pay grade. That is really up to Congress. However, we 

are in a threshold, and I think with devices, too, of a revolution in 

biomedicine, and we are starting to see the benefits of that. And 

we need to have the programs that can respond to that, and also 

programs that can get for those older drugs, get low cost, affordable 

generics out on the market promptly, and at the same time, shepherd those innovations, both devices and drugs, that are going to 

make a difference for people who are still suffering from untreatable diseases. 

And we really, I passionately feel we have to deliver this to the 

public. We have to make sure our regulatory programs are up to 

the task of dealing with drug-resistant organisms, of dealing with 

the new science that is coming forward. 

And we are always close to the bone, as you know, in FDA. We 

have to shepherd our resources very carefully. More is at stake 

here than just having our staff. What is at stake is are we going 

to translate these innovations into benefit for the public. 

Ms. CASTOR. Thank you. 

Mr. PITTS. The Chair thanks the gentlelady. 

Now recognize the gentleman from Illinois, Mr. Shimkus, 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I am glad to follow my 

colleague from Florida, because obviously history, it is interesting 

in that this was the President’s proposal to go into sequestration. 

It was passed by the House. I voted for it. And the real way to 

solve sequestration is understand debt, deficits, and our entitlement programs, and get those reforms. 

My fear for any agency, that without that the expansion of our 

entitlement programs is going to squeeze out the discretionary 

budget, whether that is the military, whether that is your agency. 

And the sooner we as a Nation own up to that, then we wouldn’t 

be having this debate. 

One of the great things I love about the job of being a Member 

of Congress is working with our constituents. So right during votes 

I had one of my constituents go, and we measured the Ohio clock, 

because I have a constituent who is building a replica. So we were 

tape measuring and stuff. So that is an example of kind of the 

things that we do. 

45 

And it is just lucky that you are testifying when I was approached by a constituent, a member of my church. And so I am 

going to get a privacy release statement and we are going to follow 

up with the FDA, but he was supposed to be in clinical trials in 

September. They have not been called. He has asked me to ask 

why. So if you all would just be prepared for when we get involved 

with that, I would appreciate that on behalf of my constituent. 

So having said that, really my questions are to Dr. Shuren on the 

510(k), some issues revolving with that, which I have been trying 

to follow closely. Many companies are providing us feedback that 

they are experiencing a significant shift in requirements for various 

510(k)s. Particular concerns have arisen about new requirements 

being communicated by the FDA during the 510(k) review that go 

beyond previously sufficient data requirements. 

If true, this concerns me because in many instances FDA has not 

issued any new guidance on public communication regarding policy 

changes. So the question is, has the FDA changed its data requirements for submission types without issuing updated guidance documents? And if so, can you tell me why the change in consistency? 

Mr. SHUREN. Well, first of all, I will say that oftentimes if we are 

asking a company for additional data, sometimes it is in response 

to the data they provided to us, that there may have been issues 

in what was submitted. 

One thing I will ask you is, if you have companies who believe 

that something has been changed and changed inappropriately, you 

are very welcome to send them to me directly, and I promise you 

I will look into it. 

Mr. SHIMKUS. Thank you. 

At hearings in this committee prior to the enactment of FDASIA 

you acknowledged that in some cases the CDRH reviewers were 

asking for data to support product applications that they should 

not be asking for. You also indicated in an October 2011 document 

that you planned to work on training reviewers to avoid these sorts 

of data requests. Can you give us an update on this and what steps 

have you taken to address this? 

Mr. SHUREN. So we have taken a variety of steps to assure that 

the questions that we ask are need to know rather than nice to 

know. And I will tell you even from our own analysis it is not common, but it happens, and it concerns us. 

So one of the things we have done is we have been reorganizing 

in our premarket review offices, and thanks to MDUFA III we have 

been bringing in additional managers for more oversight of the 

process. We have changed policies and procedures to put more 

checks into the system. 

Under MDUFA III, we have also put in a back check. So with 

our high-risk devices, we actually have a dedicated staff who will 

review any and all major deficiency letters that go out for accuracy 

and appropriateness. We have biweekly premarket review rounds, 

where if issues get raised we are dealing with them with the reviewers and the managers at that point. And of course we have 

done training for everyone for starters. 

Mr. SHIMKUS. And I will end up on this. What, if any, consequences are there for reviewers who ask questions beyond what 

is appropriate? And are those annotated on their performance reVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
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view evaluation so that if it happens numerous times? Many of us 

have been managers of personnel. And, you know, the reality is you 

have got to document, document, document, especially on a Federal 

employee who may not be responding to the proper directions. 

Mr. SHUREN. Well, I will first say, and I am going to put this in 

because my folks get sometimes a hard rap, they are a great group 

of people. They are very smart, they are dedicated, and they have 

been working exceptionally hard to implement FDASIA and to 

make changes. And I think it is reflected, quite frankly, in our premarket review numbers. The bottom line is our performance is getting better, and it is getting better for the first time in a decade 

of worsening, and that is a lot of credit to them. 

Making changes is hard when it is a large organization, and 

there are going to be blips along the way. And it is our responsibility to keep good oversight in the center. And when things do 

arise, we do engage with the individual. We try to educate and 

work with them and keep on top of it. 

Mr. SHIMKUS. If the chairman would for just a follow-up, of 

course, annotating if there is numerous examples and writing it 

down is part of a good personnel status. So I hope you would consider and do that. 

Mr. SHUREN. Yes. And I will say for anyone who is not performing appropriately, and that goes for anything, then appropriate 

documentation in the file, and also discussions with the employee, 

because you always want to, if an employee isn’t doing well, to try 

to help them to get back on par with performance. 

Mr. PITTS. The Chair thanks the gentleman. 

And now recognize the gentlelady from California, Ms. Capps, for 

5 minutes for questions. 

Mrs. CAPPS. Thank you, Mr. Chairman. 

And thank you to our witnesses for being here today. I am so 

pleased that we were able to reschedule what I consider to be a 

very important hearing. And I am very pleased that FDASIA included parts of my Sentinel Assurance for Effective Devices Act, 

also known as the SAFE Act, in its final form. 

One section of that bill was to ensure swift release of the UDI, 

the unique device identifier rule, for public comment to improve device tracking and aid in any potential recalls. So, Dr. Shuren, I 

want to commend you for getting the final rule out on UDI. I know 

it has been a long time coming, and I am glad that you finalized 

it so things can finally move forward. 

One concern we have heard from consumer groups has been that 

the final UDI, unique device identifier—I want to make sure people 

know what I am talking about—rule does not require the identifier 

to actually be on the individual product itself. Can you explain the 

decision to not require the UDI to be on each one of these products? 

Mr. SHUREN. One of the principal drivers was cost, cost to the 

companies. And we want to make sure that in implementing and 

putting forward this important regulation that we keep in mind 

what the burdens may be for companies to try to comply. So that 

was the major reason. 

We do still keep in marking the devices in really one exception, 

and that is if you make a device that is going to be used more than 

once and it is going to be reprocessed. Because in that case, the laVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
47 

beling that came along with the product that had the UDI got 

thrown away, now it is moving over to someone else, and you 

wouldn’t know what that device is unless you marked those devices. And that is a requirement in the rule. 

Mrs. CAPPS. OK. OK. That is good to know. 

My SAFE Act also built upon the existing Sentinel program at 

FDA, a program that enables FDA to actively query automated 

healthcare data to evaluate possible drug safety issues quickly and 

securely. The SAFE Act, and section 615 of FDASIA, both broadened that usage to the medical device space, which will benefit producers and consumers alike by catching problems early and ensuring that data, not conjecture, but data determine our device safety 

policies. 

Unfortunately, the rollout of Sentinel on the drug side has taken 

many years, more than many in the field think is necessary. So I 

hope that expansion to the device side will not be plagued with the 

same delays. And can you each give me a brief update on where 

the agency is with Sentinel? I would appreciate a longer update for 

the record. 

[The information appears at the conclusion of the hearing.] 

But just quickly, can you also explain for us how UDI fits into 

FDA’s postmarket surveillance of medical devices? Will it be good 

for patients and for providers and for manufacturers? 

Mr. SHUREN. So the UDI is absolutely essential. It is a condition 

precedent for having Sentinel for medical devices. And the reason 

is right now it is very hard to link a device with a patient’s experience with that device in electronic health information, electronic 

health records. Unlike drugs, which had a new drug code that they 

could use right away, we didn’t have anything for devices. So the 

UDI we need to have in place. And that is going to take a few 

years. 

But in the interim, what we are also doing is the following. We 

are identifying, helping to develop new and validating tools for active surveillance, being able to go through information to find out 

what are better understanding of benefits, risks, and problems with 

devices, And we are working with our conflicts in CDER on that. 

Also, Sentinel will be part of a broader National Medical Device 

Postmarket Surveillance System. So electronic health information 

and registries will be the backbone. And we view this not so much 

as an FDA system, but truly a national system to meet the needs 

of industry, healthcare providers, insurers, FDA. 

So moving forward, the Brookings Institution is very soon going 

to call for the creation of a multistakeholder planning board to 

start to lay out the governance structure, policies, and procedures 

for such a surveillance system, which we think is important not 

only for identifying problems, but being able to use postmarket information to help lower burden and better inform decisions on premarket approval, help products get to market, help doctors and patients make better-informed decisions. 

Mrs. CAPPS. Thank you very much. 

And finally and briefly, another piece of FDASIA was a key component of my HEART for Women Act, bipartisan legislation that focused on doing all we can to address women’s heart health and address health disparities. Section 907 of the FDASIA required an exVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
48 

amination of the extent to which data on how approved medical 

products affect women, minorities, and ethnic groups be collected, 

analyzed, and publicly reported. This is an important step, but concerns persist I know, and I will be submitting many questions for 

the record, and I appreciate your team’s attention to this matter. 

And I don’t think there is much time for you to respond. I just 

wanted to put that out. We will follow up with you. Thank you. 

Mr. PITTS. The Chair thanks the gentlelady. 

And now recognize the gentleman from Pennsylvania, Dr. Murphy, 5 minutes for questions. 

Mr. MURPHY. Thank you, Dr. Shuren and Dr. Woodcock. I appreciate you for being here today. 

I would like to take just a moment to ask you about an important medical device issue, although it was not part of FDASIA. The 

FDA has regulations about proper maintenance of complex medical 

devices such as radiation therapy and imaging equipment, and 

manufacturers are required to recommend maintenance standards 

to hospitals and physicians and collect data on how that equipment 

is kept and serviced. 

My understanding is that the Center for Medicare and Medicaid 

Services may issue guidance telling hospitals they are free to vary 

from the manufacturer’s maintenance recommendation on these 

types of devices. But we are not dealing with an automobile or refrigerator here. These are highly specialized pieces of equipment. 

And when a medical device is improperly serviced, the consequences can be pretty deadly, as you know. 

When a New York Times series in 2010 raised concerns about 

patient deaths from improperly calibrated diagnostic and therapeutic equipment, this committee held hearings in the matter. I am 

concerned that weakening of equipment maintenance standards 

could have some severe consequences for patient safety, and the 

party responsible for that device is the manufacturer. If something 

goes wrong, it is that company’s name on the label, even though 

they are not the ones that made the maintenance changes. I believe the FDA has weighed in on this possible action by CMS. Is 

that true, Dr. Shuren? 

Mr. SHUREN. Yes, that is true. 

Mr. MURPHY. Can you discuss the FDA’s position on this and you 

concerned about anything there? 

Mr. SHUREN. Our concern is that the maintenance schedule is 

really part of assuring that that device remains safe and effective. 

And we work with the companies on what is the appropriate maintenance schedule to assure just that. And as you mentioned, these 

are technologies that may be emitting radiation, and we want to 

make sure not only are you getting accurate images of patients, 

you want to make sure they are also getting the right amount of 

radiation, not too much. And so a good maintenance schedule is essential. And that is why we had raised certain concerns and shared 

those with our colleagues at CMS. 

Mr. MURPHY. OK. Let me ask another issue here. And I will gave 

you a little briefing material on this a little bit ago, but I want to 

make sure we have it in the record. We are all concerned about 

hospital-borne infections. E. coli, MRSA, and other infections which 

spread in hospitals are particular risks for people in hospitals, parVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
49 

ticularly in an ICU, or people who are immuno-compromised, et 

cetera, in transplant patients, et cetera, and that people use substances that are put into paints and plastics and clothing to try 

and reduce infections. But there also is the element of copper, 

which in research I understand has shown that basically E. coli, 

MRSA, and some other diseases are killed in minutes, whereas 

those same diseases can last for weeks on plastics and stainless 

steel. 

The EPA has said that any sort of regulation on this is in the 

FDA’s hands and they are not going to do anything about it, even 

though they have other jurisdiction over copper. I wonder how this 

will work at the FDA in terms of expediting this. I mean, it is obviously not a new element. It has been around for billions of years. 

And it seems to me it ought to be something we can use, copper 

itself, or copper-nickel alloys and other alloys which we know that 

can be on handles, on trays, on other equipment and supplies 

where these diseases can be killed right away. 

Can you comment on the procedures you could take on this? And 

could anything be sped up on this process? 

Mr. SHUREN. So we are happy to look into it. If it is a medical 

device and it has copper on it, if it has an anti-infective, that is 

something that my center would generally take care of. If it is not 

on the medical device, so it is just the anti-infective, it tends to 

work by a chemical action, becomes a drug issue. And that is why 

if there is a company or companies dealing with it, it is important 

that we connect so we figure out exactly what we are trying to do 

and help them as best we can. 

Mr. MURPHY. Just help me understand this, because I want to 

make sure we handle it in the right way. So if it is a door handle 

or a touch plate entering an ICU, if it is a switch plate in a hospital room, would those be medical devices or would they be——— 

Mr. SHUREN. So a lot of those basics oftentimes are not. 

Mr. MURPHY. What category would they be in? 

Mr. SHUREN. If you are talking about surgical instruments, you 

are now getting into——— 

Mr. MURPHY. I understand that. I understand that. So what category would they be in? Because the EPA is saying that FDA has 

to approve them. 

Dr. Woodcock, do you have——— 

Ms. WOODCOCK. They would only considered a drug if they actually had a disease claim in humans. And we don’t usually regulate 

door knobs as drugs, all right. I think we are talking about some 

jurisdictional, like, murkiness here that we would need to sort out. 

Mr. MURPHY. Well, I would just hope. Let’s put that on the 

record. We will get you the information on it. But I hope that is 

something that you and the EPA can discuss fairly quickly. Obviously, the 100,000 people who die every year from hospital-borne 

infections and the fifty billion dollars we spend, if this can be reduced by several, then we ought to work together. 

Thank you so much. I appreciate it. 

Mr. PITTS. The Chair thanks the gentlemen. 

Now recognize the gentleman from New York, Mr. Engel, 5 minutes for questions. 

50 

Mr. ENGEL. Well, thank you very much. And welcome to both of 

you. Followed both of your work. And thank you for your service. 

I believe that the good work done by this committee on the Food 

and Drug Administration Safety and Innovation Act was likely the 

best healthcare-related legislating done by Congress last year. A 

little more than a year after its passage, I am pleased that this 

hearing is taking place so we can continue to monitor the implementation of this important bipartisan law. 

I have always fought for those with rare and orphan diseases. I 

am the author of the ALS Registry Act, and both the Paul D. 

Wellstone Muscular Dystrophy Community Assistance Research 

and Education Amendments of 2008 and 2013, which I have done 

with Congressman Burgess. I am particularly interested in the development and approval of drugs for rare diseases. 

Therefore, one of the aspects of FDASIA I am most interested in 

is the improvements made to the accelerated approval pathway as 

part of the law. To me, diseases like muscular dystrophy are why 

the accelerated approval pathway is so important. Duchenne muscular dystrophy is the most common lethal genetic disorder of children worldwide, affecting one in every 3,500 live male births. There 

is no cure. It is always fatal. And the best hope for those with 

Duchenne is to treat the symptoms and delay its progression. I 

have a group of people in my district that called this disease to my 

attention. 

However, in recent years the Duchenne research pipeline has 

held much promise, as potentially life-saving therapies appear on 

the horizon, making elements of FDASIA particularly relevant to 

this research community. Earlier this week, the FDA informed 

Sarepta Therapeutics that its experimental drug for Duchenne 

muscular dystrophy was not a candidate for the accelerated approval pathway at this time. I recognize that since Sarepta has not 

filed its new drug application most of the discussions between 

Sarepta and the FDA are confidential. But I hope that Sarepta will 

continue to pursue their treatment for Duchenne muscular dystrophy, and I hope that the FDA will continue to provide clear feedback to the company as they move through their various clinical 

trials. 

So, Dr. Woodcock, can you elaborate on how you envision the enhanced accelerated approval pathway working? 

Ms. WOODCOCK. Certainly. As I said, in fiscal year 2013 we approved a large number of rare diseases, and all of them were based 

on surrogate end points, which is the foundation for accelerated approval. However, we granted a number of them full approval because we felt enough information had been provided that a confirmatory trial would not be necessary. 

So we certainly are using the accelerated approval in rare diseases. And what the FDASIA instructed us to do was to really consider additional end points, including intermediate clinical end 

points, in other words clinical end points that are reasonably likely 

to predict clinical benefit, and we intend to do that. 

Mr. ENGEL. Thank you. Let me ask you another question. Recognizing the challenges in developing therapies within the rare disease space, how is the FDA working with companies to ensure 

proper parameters for success and failure are being established 

51 

through the clinical trial process in order for experimental medications to possibly be considered under the accelerated approval 

pathway? 

Ms. WOODCOCK. We try to work one by one, because of course 

each one of these diseases is different. One of the most important 

things that can be done by the patient communities is to establish 

a natural history of the disease through data so that we understand and can predict what will happen. If there is an intervention, 

you can calculate how many patients you need in your trial and so 

forth. 

And this hasn’t been done before. And so we have really been 

pressing on that, and I think we have seen a lot of progress. But 

we work with the companies one by one to help them design their 

trial. And as I said, we have set up a rare disease staff, although 

that has been inhibited because some of that money has been influenced by the sequester. 

Mr. ENGEL. Well, thank you. And let me talk about the sequester 

and building on what Ms. Castor asked. I didn’t vote for the Budget Control Act of 2011, thankfully, which created this huge sequestration mess. I am very frustrated that the user fees paid as part 

of agreements reached in FDASIA are being sequestered. So why 

don’t I ask Dr. Shuren, can you talk about how sequestration impacts the ability of the FDA to meet goals agreed upon as part of 

FDASIA? 

Mr. SHUREN. It is making it challenging. I mean, we are meeting 

the goals now. But in 2013, we saw about an 8 percent cut. Critical 

funding for training of our staff, of our review staff who we want 

to be on top of cutting-edge technology. Saw a 15 percent cut in our 

ability to recognize national and international standards, which 

provides predictability for industry. We had a 50 percent cut in our 

investment in regulatory science to have better tools for assessing 

medical devices faster and at lower cost, which is a big deal for industry. And I had to shift 50 percent of my operating dollars into 

payroll in order to hire the people I committed to hire under 

MDUFA III. 

So most of my extra money, if you will, beyond paying for employees, is to pay for the rent, keep on the lights, put money in the 

photocopier. I have very little to actually put in to really improve 

a program that still needs a lot of help. And if we go into 2014 and 

this continues, I am not going to have the money to be able to hire 

and maintain the people we committed to hire and maintain under 

MDUFA III. It is a big deal for us. 

And sequestration, it is important on user fees. Most of our program is still funded by appropriated dollars. And those cuts, they 

are killing us. And we are a program, like drugs, where years before trying to actually turn the program around, and this is making 

it very challenging for us to do that. 

Mr. PITTS. The gentleman’s time has expired. 

Mr. ENGEL. Thank you. 

Mr. PITTS. The Chair recognize the gentleman from Virginia, Mr. 

Griffith, 5 minutes for questions. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. 

Dr. Woodcock, greatly appreciate the passion you showed earlier 

in your testimony. I would agree with you on that passion, particuVerDate Mar 15 2010 09:12 Dec 10, 2014 Jkt 037690 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 C:\PROGRAM FILES\WS_FTP\91626.TXT WAYNE
52 

larly about bringing innovative treatments for rare and terminal 

diseases. I have a little bill that would allow folks to get early access or early approval to those drugs in order to help them, and 

what we believe will actually lower the costs of some of that experimentation. We will talk about that another time. 

I do want to talk about a bill, I know what we are doing here 

today is important, but I do want to talk a little about a bill we 

have waiting over in the Senate. The House passed the Drug Quality and Security Act. It was a bipartisan, bicameral compromise to 

prevent another fungal meningitis outbreak like the one associated 

with NECC’s tainted sterile products, where we had 64 Americans 

unfortunately died as a result of that situation. 

I am proud of the legislation that I worked on with Congressmen 

Gene Green and Diana DeGette. Ultimately, although we had a different package originally, we came to a compromise with our Senate colleagues and with your agency, and I look forward to the Senate getting around to it. It is held up for other reasons, but I look 

forward to the Senate passing the bill and it being signed into law. 

And I am committed to engage in oversight to make sure that 

patient safety is being properly protected. I also look forward to the 

agency developing the notification system that Congressman 

Green, Congresswoman DeGette, and I authored to ensure that the 

FDA works more closely with those State boards of pharmacy to 

prevent another public health crisis. 

That being said, there were some areas that we thought we 

might be able to get fixed that we didn’t in that bill that have 

raised some concerns. And I would like to ask you about those in 

regard to that Drug Quality and Security Act. In its previous draft 

guidance the FDA recognized the importance of maintaining an office stock of compounded drugs that doctors can readily access and 

administer to patients in their offices. Can we rely on the agency 

to continue to allow doctors and hospitals to order and keep compounded drugs on hand for office use? 

Ms. WOODCOCK. Well, we are going to have to see what is in the 

final bill, if it is enacted. And then as I understand it, it really removed the court disparity, which I didn’t fully understand, but was 

a problem. And so it leaves the previous statute more or less intact, 

and we can implement it aggressively. And obviously, that is one 

of the considerations in there, is what are the four walls of what 

is Federal, what is State, and what is permitted. 

Mr. GRIFFITH. And we didn’t change anything in regard to office 

use, and so there is some concern that maybe we should have put 

it in. It was compromised that we would just leave it silent. And 

I hope that we can count on the FDA. I know you maybe can’t answer that today. But I would hope that we can count on the FDA 

to leave that part of it that was working very well, which the FDA 

had previously done, leave that intact, because I don’t think there 

was any intention, certainly not on our side, that that be changed 

in any way. 

Likewise, repackaging of sterile drug products has typically been 

regulated by the agency in the same fashion as compounded drugs. 

Repackaged sterile drugs are vital for many patients, especially 

those in ophthalmologic health issues. Likewise, can we rely on the 

FDA not to go in and create chaos, and to preserve the access to 

53 

these repackaged sterile drugs and limit the impact of burdensome 

regulations on that practice? 

Ms. WOODCOCK. Well, our intent certainly is not to create chaos. 

Mr. GRIFFITH. Yes, ma’am. 

Ms. WOODCOCK. All right? I think one of the goals, mutual goals, 

is to prevent contaminated drugs. And that is really our goal, and 

your goal as well, I believe. 

Mr. GRIFFITH. It is. There were some clarifications that everybody decided to let go and hope that it works out. And so I am just 

worried about those areas. 

The last of the three that I have is the nuclear pharmacists. 

They compound drug products that have a short radioactive half 

life and must be quickly delivered to a healthcare entity for administration to a patient. Sometimes this must be done in advance of 

a patient-specific prescription. Can we rely as well on the FDA to 

continue to try to monitor that in the same fashion that they did 

before this bill was passed? And I know that the Senate is either 

going to pass it today or next week. But anticipating that, since it 

was a compromise worked out between the two bodies and the 

FDA, what are your thoughts on that? 

Ms. WOODCOCK. Well, the nuclear pharmacies have not represented a problem here. We have a scheme with them. We have 

been very successful in implementing a regulation of positron emission tomography facilities, and that has gone very well. And so I 

think we should continue along that path. 

Mr. GRIFFITH. And I appreciate that greatly. And I would be remiss, you know, it is good to see a witness with passion and your 

dedication. We may not always agree on how to get there, but I always appreciate the fact that you come in with honest answers and 

a willingness to try to work things out, and I appreciate that. 

Ms. WOODCOCK. Thank you. 

Mr. GRIFFITH. With that, Mr. Chairman, I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

And recognize the gentleman from Maryland, Mr. Sarbanes, 5 

minutes for questions. 

Mr. SARBANES. Thank you, Mr. Chairman. 

I just want to pick up on the end of those comments, and thank 

you, Dr. Woodcock, for being here, and say you are one of the most 

professional and knowledgeable witnesses we have the pleasure to 

bring before this committee from time to time. I thank you for your 

testimony, and yours as well, Dr. Shuren. 

And I want to thank the chairman for convening this panel today 

and the committee hearing so we can get a sense of how things are 

progressing. These days, sort of bipartisan legislation that we all 

get behind is hard to come by, so it is nice to have the opportunity 

to hear that good things are already resulting from the passage of 

this reform, and we appreciate your testimony in that respect. 

I was going to ask as well about how the kind of user fee resource has gotten caught in the switches of sequester, which I 

think you have answered that. It is particularly jarring I think to 

the industry, the notion that they are putting forward through the 

user fees resources from the industry, and even that gets implicated by the sequestration that has been put in place. And hopefully, we can address that for all the reasons that you have raised. 

54 

I don’t have a lot of questions necessarily on the topics you have 

been covering because I think you have done a good job addressing 

them. I did want to ask something slightly off topic, which is, as 

a result of redistricting in Maryland, I now have the privilege of 

representing some portion of the White Oak facility and had the 

opportunity to get a tour recently and see the tremendous facilities 

that are provided there. And I wondered if you could just speak to 

the benefits of now being able to collocate so many of the FDA personnel and have the labs there near each other and what that represents in terms of the ability of the agency to function. 

Ms. WOODCOCK. Well, we really appreciate this, because CDER, 

when I took over CDER, first it was in 14 different locations scattered around the metropolitan area here. We expect a move this 

summer that will move the generic drug program to the White Oak 

campus, and also move the biologic therapeutics regulation, which 

has been located on the NIH campus, with their associated laboratories, to White Oak. And also our colleagues in the biologic center, 

with whom we work on policy very closely. 

So for the drug center, this is a tremendous advance, will allow 

us both to have our new generic office on campus, as well as build 

our quality regulation organization, which I spoke about earlier, 

where we are going to have the same unit regulate pharmaceutical 

quality across all different types of drugs. 

And also it will enable us to work with our colleagues at CBER 

very closely. And the benefits of having the device center right near 

us are tremendous, because there are many combination products 

with this new technology that is coming about that combine device 

elements and drug elements. So this has been a tremendous advance for us. 

Mr. SHUREN. It has been a big deal for us as well. I would also 

put a plug in on personalized medicine. So much of it depends upon 

having the right diagnostics tied up with the therapeutics, and we 

work very closely with our colleagues in CDER. Having them down 

the hallway is essential. 

And having the lab facilities to do absolutely critical work. And 

that is work that also helps companies. Getting product to market 

is so important. And one of the challenges we face in the current 

budget climate is we are getting to the point, getting very close to 

the point of starting to turn off lights in some of those labs. 

Mr. SARBANES. Thank you very much. I yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize Mr. Guthrie 5 minutes. 

Mr. GUTHRIE. Thank you. Thank you for coming. And this is a 

good hearing. And it is one of those things that when you run for 

Congress you don’t think about these kind of issues. You have 

other things that you more readily read about. But when you get 

here, you realize they are vitally important to your constituents. 

We have people come continuously, and they are looking for devices, they are looking for approvals. And I think Mr. Shimkus 

talked about one specifically that is in a desperate situation. So it 

is important that we work together. 

And I have a couple of questions. One is on the custom devices. 

And, Dr. Shuren, this would be for you. Those that are made by 

manufacturers for specific patients upon request by their physician 

55 

are critically important for patient care, but are not viewed by 

many as efficient or lucrative. And so therefore, in section 16 of the 

FDASIA, we established that manufacturers could modify an existing device for which data already existed instead of making an entirely new device. 

The FDASIA language limits the manufacture or production of 

five units per year of a particular device type. And some in the industry have expressed concerns that the FDA may interpret this to 

say it can only be for five patients per year versus just five devices—only five patients who needed a custom device. And I think 

that might render that kind of ineffective. And so I just wonder 

how you interpret that provision. 

Mr. SHUREN. No, we are not putting such a strict limitation on 

it. In the next few weeks we are going to put out draft guidance 

to try to better clarify implementation of that provision, which we 

think are very important provisions. And we support custom devices, and we think it is so helpful that Congress actually put in 

a much more clear standard for what is a custom device. And we 

are going to provide that clarity then in terms of interpreting it. 

I would also add that companies do not need to come to us in 

order to go out with a custom device. There is no premarket review 

on it. They simply report to us annually. So hopefully in the next 

few weeks we will have out that guidance so we can have a fuller 

discussion with industry about it. 

I will also say in those cases where they don’t meet the statutory 

definition of a custom device, there are other mechanisms we have 

in place to help assure that patients who need a device that isn’t 

otherwise approved on the market can get it. So many of those 

cases, even if the law doesn’t allow a custom device, could be for 

compassionate use and still get it to the patient. 

Mr. GUTHRIE. I know in the reporting that it makes it quicker 

and better for the patient. I guess there was some concern it might 

just be five patients. So in a couple weeks you are going to have 

that guidance, and if you could keep us informed, that would be 

fantastic. 

I do want to point out that, I know we talked about sequestration, and we are dealing with budget issues here, and the budget 

conference committee is meeting as we speak through December, 

but the FDA has experienced a dramatic increase in appropriations 

over the past decade. And since the beginning of MDUFA, CDRH 

has gone from approximately 1,000 MDUFA full-time equivalents 

to over 1,400. And since 2004, CDRH has doubled its budget from 

179 to 385. That is from 2004 to fiscal year 2011. And during this 

time PMA and 510(k) submissions have decreased. 

However, studies have shown, and that is the CHI/BCG report 

we are all aware of, that review times have gotten 43 percent slower in the past few years and PMA 75 percent longer. So sequestration does have an effect, I am not saying that it doesn’t, but there 

has been some substantial increase in the budget at the FDA as 

well. 

So, Dr. Woodcock, one of the central tenets of the Prescription 

Drug User Fee program is to provide more certainty and predictability on the timeline for FDA to make decisions to approve a 

drug. And why is it important for companies in terms of continued 

56 

innovation and patient access to new medicines for companies to 

have predictability on the FDA and when it will make decisions on 

application? 

Ms. WOODCOCK. Well, because these companies invest up to a billion dollars in a development program, and then they need to 

launch, and they have to do a lot of activities to get ready for 

launch. They have to get their facility all ready, distribution chain, 

all sorts of things. And so just knowing what the sequence of 

events is going to be and when that time on to market will be is 

extremely important to keep this enterprise afloat. 

Mr. GUTHRIE. I agree with you. And then do companies receive 

patent term restoration based off the time it takes for a company 

to go through the FDA process? 

Ms. WOODCOCK. Well, I don’t understand this very well. They get 

restoration at the time of approval. So they get that. But there can 

be things eating away at their patent in the interim. 

Mr. GUTHRIE. OK. And it is important, because our investment 

in research is second to none in the world. And I know, we talked 

in my office, Dr. Shuren, on some of the device companies that are 

going to other countries for better opportunities to get approval of 

their processes. And I appreciate the work that you have done on 

that, because we don’t want to lose our industry and our leadership 

in research, and certainly not because of slow and unpredictable 

processes. So thanks for working to make that better. 

And I yield back. 

Mr. SHUREN. Thank you. If you may, Mr. Chairman. 

Mr. GUTHRIE. I have three seconds. Go ahead. 

Mr. SHUREN. And we are starting to see some changes. I just got 

called this week by a company who said we were actually going to 

conduct our first-in-human study overseas, and given the changes 

at the FDA they were going to start it in the U.S. And we are hearing that from other companies as well. 

The numbers you gave in terms of our performance, they are 

from a report from 2010. And that is actually what I would say was 

the high point, the watershed mark for the program after about a 

decade of worsening. And since that time those numbers are actually down a fair bit. They are improving in review. 

Mr. GUTHRIE. I understand. And I hope I didn’t insinuate that. 

But I was just saying the funding has doubled since 2004. So there 

has been increased funding even though you are under sequestration now. So I just want to make that point. 

Mr. PITTS. All right. The gentleman’s time has expired. That concludes the first round of questionings. We will go to one follow-up 

per side. 

Dr. Burgess, you are recognized for 5 minutes for a follow-up. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Dr. Woodcock, can I just ask you briefly about the decision by the 

FDA to reschedule hydrocodone? Is there any update you can provide us on that? 

Ms. WOODCOCK. Well, let me explain the process. What we do, 

we were asked, along with NIH, the National Institute for Drug 

Abuse, to provide a recommendation to HHS, who then provides a 

recommendation to DEA, who then go through a formal notification 

and comment process. And DEA actually does upscheduling. So 

57 

what we announced was simply the fact that we intended to recommend that the combination products be upscheduled. 

Mr. BURGESS. Now, is there a report pending from FDA that we 

have not yet seen or has not yet been made public? 

Ms. WOODCOCK. Correct. What we need to do to actually any 

scheduling action, we send something called an eight factor analysis, which is stipulated under the Controlled Substance Act, and 

findings based on that. And we write that up and send that to 

HHS, who then will evaluate it and then send recommendations to 

DEA. And that process, we should be moving that process along 

fairly soon. We expect to. 

Mr. BURGESS. So we will have access to that report? 

Ms. WOODCOCK. I don’t know what point it becomes public. We 

can get back to you on that part of it. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. OK. Thank you. Well, you know, and it is a concern, there being practicing physicians all over the country who— 

sure, there are some things that require—State law requires triplicate prescription in Texas, those things can’t be called in over the 

telephone in the middle of the night. But someone who has run out 

of a postoperative medication and still needs help, the doctor has 

the ability to get that help to that patient without an emergency 

room visit. So it is important, and it is something I don’t want to 

see us lose. 

We had a hearing here on, I guess it was on putting the EpiPen 

over the counter, an over-the-counter Epinephrine treatment for 

bee stings. And I don’t remember now, quite honestly, who was 

here from the Food and Drug Administration that day, but I asked 

the question was there any thought to putting Narcan over the 

counter, Naloxone, so people would have the availability for that if 

they got into trouble abusing drugs that either they got legitimately or illegitimately. And then that was a feature of a story on 

Sanjay Gupta on CCN not too terribly long ago. 

So where are we in that process? We have gone to great lengths 

to make levonorgestrel not just over the counter, but down there 

with the Snickers bars in the front of the pharmacy. Is there ever 

going to be any effort to make Narcan over the counter? 

Ms. WOODCOCK. We are certainly encouraging development of 

forms of Naloxone. As you know, now it is compounded as nasal 

sprays and so forth and used by paramedics. So we are certainly 

encouraging development of sort of dosage forms that can be used 

out in the field under emergency situations. And then we would 

certainly consider whether over-the-counter access would meet the 

criteria for over the counter and then would improve emergency 

treatment of overdoses by friends and relatives, for example. 

Mr. BURGESS. Well, thank you. Again, it was a pretty startling 

film clip that Dr. Gupta showed on that series, and again made me 

think again about the possibility that—again, no one wants to condone the use of illicit drugs, but on the other hand you hear about 

it where you lose—usually it is a teenager in our community and 

it is a terrible tragedy when it happens. And if there were another 

option maybe that would be a good thing. 

58 

Ms. WOODCOCK. We totally agree with you, and if lives could be 

saved that way then that is something we should really drive toward, and we are very aggressively pursuing this. 

Mr. BURGESS. Don’t misunderstand me, Mr. Chairman, it would 

be better if they never abused the compounds in the first place, but 

as a matter of first aid perhaps that is something should be considered. Thank you for the recognition. I will yield back. 

Mr. PITTS. The Chair thanks the gentleman. 

And now for follow-up, Mr. Sarbanes for 5 minutes. 

Mr. SARBANES. Thank you, Mr. Chairman. 

Dr. Shuren, I know when last year we were debating the various 

proposals around this reform one of the issues was where to draw 

the line, what the proper balance should be in terms of regulating 

medical devices. We wanted to make sure that, you know, on the 

one hand we had sufficient regulation in place and you had sufficient authority at the FDA to ensure that these devices are safe 

and effective and so forth. At the same time not have so much regulation that it becomes burdensome on industry to a point of sort 

of quashing innovation and investment. 

And I would be curious generally for your thoughts on how industry has responded to where we kind of put that line where we 

struck the balance. And in particular I would be curious to hear 

you talk about the new, more streamlined process you have with 

respect to classification of devices from class 1 up to class 3, where 

I gather now you can use a kind of administrative process that 

doesn’t necessarily involve full-blown rulemaking and comment, so 

forth, in every instance. And maybe you can give some examples 

of how you have used that authority in an effective way. 

Mr. SHUREN. So, I mean, to answer the first part, I think after 

much discussion that occurred last time around FDASIA there was, 

I will say, general support for the U.S. standard of reasonable assurance of safety and effectiveness. And the question then becomes, 

what does that actually look like for particular kinds of devices? 

What we have done is put in place this new benefit-risk strength 

work that is much more flexible and patient-centric to try to set 

the needle, if you will, in the right place. 

One of the things that we are going to be following up in the 

coming months is to start talking about those circumstances under 

which data we might otherwise collect premarket can be shifted to 

the postmarket setting and not compromise patients, but do an appropriate reduction of burden on companies and address some of 

those cases in the postmarket setting. And that will include some 

new pathways for high-risk devices as well, and I think that is important. 

Regarding classification, FDASIA provided some important 

changes to the process. One is the fact that we can now issue an 

order rather than a regulation. So in some respects it has gotten 

a little easier, and it has been helpful. 

But let me tell you one wrinkle we have, and that is where if we 

do want to in fact reduce burdens on companies, appropriately so 

because with more experience we realize we should lower the classification, we should go from class 3 to class 2, or class 2 to class 

1, we actually now have more steps to go through. We must hold 

an advisory committee meeting where before we didn’t have to do 

59 

that. And that is actually making it more challenging for us under 

appropriate circumstances to reduce regulatory burden on companies. 

Mr. SARBANES. Thanks very much. 

Mr. PITTS. The Chair thanks the gentleman. 

We have had a couple of members detained on the floor and 

missed the first round, so I will ask unanimous consent to recognize them as they come in for 5 minutes. 

Dr. Gingrey, you are recognized for 5 minutes. 

Mr. GINGREY. Mr. Chairman, thank you for that courtesy. 

Dr. Shuren, the Office of Combination was created to deal with 

products that combine drugs, devices, or biologic products. For instance, some companies are toying with the idea of combining 

drugs and devices into solutions for antibiotic infections, something 

that I care about personally, as you know. However, the current 

approval method forcing companies with a mainly device product to 

go through a drug pathway because it induces a chemical reaction 

may discourage companies from investing in new and breakthrough 

technologies because the pathway is not best suited to what their 

product is. 

The drug and device pathways were originally created decades 

ago when the reality of combination products were not yet realized. 

What steps is the FDA taking in light of its current 1970s framework to work directly with these companies who present the agency 

with 21st century technology like these combination products? 

Mr. SHUREN. So the agency in setting up the Office of Combination Products, which sits in the Office of the Commissioner, is there 

to try to help determine what is the appropriate pathway for those 

combination products to go through. And they have been more recently trying to provide clarification for when the primary pathway 

would be device or drug. 

But when it is a combination product there are needs that would 

be met for both, let’s say, if it is a device and a drug, for the device 

side and for the drug side. So even if it is a product that we have 

primary responsibility for, if it has a biologic component, we go to 

our Center for Biologics for a consult. If it has a drug component 

we go to our Center for Drugs. 

This is a very challenging area, I have to tell you this, because 

given the way the law is we have been able to try to minimize duplicative burden, if you will, and challenges on the postmarket side 

for reporting, or on good manufacturing processes, but when it 

comes to the standard for approving products the law right now is 

very challenging for combination product makers. 

Mr. GINGREY. Dr. Shuren, thanks you very much. 

Dr. Woodcock, the bipartisan GAIN Act took important steps to 

encourage the new development of antibiotics by focusing on incentives to new companies to keep companies in the marketplace. At 

this time can you provide me the number of qualified infectious disease products that have been designated since the law was passed 

last year, what, last year? 

Ms. WOODCOCK. Certainly. We have designated, as far as I know, 

27 products with 16 distinct active modalities. And that number 

will continue probably to increase. 

60 

Mr. GINGREY. Well, I really have to commend the FDA on that 

and realizing the desire and need for new antibiotics and acting 

quickly to implement the program. I have received plenty of positive feedback from companies, not just in my district, who have 

been able to achieve benefits through the GAIN Act. 

I think you would agree with me that more needs to be done to 

combat resistance. One issue that needs attention involves susceptibility tests, interpretive criteria or breakpoints. Now, as you 

know, Dr. Woodcock, a breakpoint is criteria used to determine a 

particular infection’s susceptibility or resistance to a specific antibiotic, and they are used by physicians in clinical decision making. 

With the growing public health threat of antibiotic resistance, it 

is increasingly important to ensure that physicians have these tools 

they need to prescribe the right dose, of the right antibiotic, for the 

right patient, in the right situation. 

Given what we know about the science behind breakpoints and 

our failure to keep pace with regulatory science in Europe, are U.S. 

patients receiving the best medical care, using the most up-to-date 

science, if the breakpoints for antibiotics are not accurate? 

Ms. WOODCOCK. Well, they would not be. We have updated these 

criteria for about 121 of the 200 main antibiotic labels that exist. 

However, we feel that it would remain more up to date if we would 

not have this information remaining in the drug labels but rather 

would be able to point to a Web page and possibly to standard development organizations who are actually out there on the ground 

in the communities and are getting the information on an ongoing 

basis. 

Even when we approve an antibiotic, we only look at a few organisms. As you well know, physicians have to use diagnostic criteria 

in the devices, the test for susceptibility, for a wide range of organisms, many of which may not be in any drug label. So we think 

we need a more dynamic and effective process that reflects the ongoing experience in the community. 

Mr. GINGREY. Dr. Woodcock, I have about 2 seconds. I want to 

ask you to commit to me today to work with my office to fix the 

breakpoint issue, as well as look toward other ideas to address the 

epidemic of antibiotic resistance, one of the chief threats to public 

health today. 

Ms. WOODCOCK. We would be delighted to do that. 

Mr. GINGREY. Thanks, Dr. Woodcock. 

And I yield back, Mr. Chairman. Thank you. 

Mr. PITTS. The Chair thanks the gentleman. 

That concludes the questions for the members. I am sure members will have follow-up questions. We would ask you to please respond promptly once you get them. 

I remind members that they have 10 business days to submit 

questions for the record, and that means they should submit their 

questions by close of business on Tuesday, December 3rd. 

A very informative hearing. Thank you very much, and thank 

you for your patience. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 12:17 p.m., the subcommittee was adjourned.] 

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